Lung Cancer With Mediastinal Lymph Node Involvement Clinical Trial
| Verified date | October 2016 |
| Source | University Hospital, Essen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer tissue. The purpose of this study is to determine whether the assessment of the hypermethylation level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy makes a contribution to lung cancer staging.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | June 2014 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - clinical diagnosis of lung cancer - enlarged mediastinal or hilar lymph nodes (>10 mm) Exclusion Criteria: - clinical condition which excludes general anesthesia |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Ruhrlandklinik - Universitätsklinikum Essen | Essen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Essen | Epigenomics, Inc |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnostic Performance of SHOX2 | Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone. | one Year | No |